Member Sign In

You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating indiv idual securities.

If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.

Results from the phase I study revealed that three- and four-factor PCCs can be used to reverse the anticoagulant effect measured by coagulation assays in patients treated with blood thinner Xarelto (20mg twice daily). The study further revealed that the three-factor PCC was more effective than the four-factor PCC on reversing Xarelto-induced changes in thrombin generation.

Bayer stated in its press release that currently there are no approved reversal agents for Xarelto. In Feb 2013, Bayer along with partner Johnson & Johnson (JNJ - Free Report) collaborated with Portola Pharmaceuticals Inc. (PTLA - Free Report) to evaluate the potential ability of PRT4445 in reversing the anticoagulant activity of Xarelto in emergency situations.

We note that Xarelto is marketed by Johnson & Johnson in the US and by Bayer outside the US.

Meanwhile, Bayer and Johnson & Johnson received a huge setback from the US Food and Drug Administration (FDA) last month, when the US regulatory body issued a complete response letter (CRL) to the supplemental New Drug Application (sNDA) of Xarelto for the reduction of risk of stent thrombosis in patients suffering from acute coronary syndrome (ACS).

Bayer/Johnson & Johnson are no strangers to setbacks regarding the ACS indication in the US. In Mar 2013, the companies received a second CRL from the FDA for Xarelto’s (2.5 mg twice daily) sNDA submission for the reduction of the risk of secondary cardiovascular events in patients suffering from ACS. The initial CRL for this indication was issued in Jun 2012, after which Bayer and Johnson & Johnson had resubmitted the sNDA for blood-thinner Xarelto in Sep 2012.

Xarelto is, however, approved for several indications in the US including stroke prevention in nonvalvular atrial fibrillation, deep vein thrombosis (DVT), pulmonary embolism (PE) and reduction of the risk of recurrent DVT and PE.

Resources

Client Support

Follow Us

Zacks Research is Reported On:

Yahoo

MSN

Marketwatch

Nasdaq

Forbes

Investors.com

Morningstar

Copyright 2017 Zacks Investment Research

At the center of everything we do is a strong commitment to independent research and sharing its profitable discoveries with investors. This dedication to giving investors a trading advantage led to the creation of our proven Zacks Rank stock-rating system. Since 1988 it has more than doubled the S&P 500 with an average gain of +25% per year. These returns cover a period from 1988-2016. Zacks Rank stock-rating system returns are computed monthly based on the beginning of the month and end of the month Zacks Rank stock prices plus any dividends received during that particular month. A simple, equally-weighted average return of all Zacks Rank stocks is calculated to determine the monthly return. The monthly returns are then compounded to arrive at the annual return. Only Zacks Rank stocks included in Zacks hypothetical portfolios at the beginning of each month are included in the return calculations. Zack Ranks stocks can, and often do, change throughout the month. Certain Zacks Rank stocks for which no month-end price was available, pricing information was not collected, or for certain other reasons have been excluded from these return calculations.

Visit performance for information about the performance numbers displayed above.